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With an aim to uniformly implement the prohibition of carcinogenic, mutagenic or toxic for reproduction (CMR) substances within the EU market, to ensure legal certainty in particular for economic operators and national competent authorities, and to ensure a high level of protection of human health, EU added all CMR substances to the list of prohibited substances in Regulation (EC) No 1223/2009 as well as deleted and revised relevant substances in the lists of restricted ingredients and permitted preservatives.
On Nov. 22, 2021, EU puts the amendments into force, but the actual implementation date is Mar. 1, 2022, with a grace period of more than three months. The detailed amendments are shown as follows:
1. Prohibited ingredients: 23 added, including Zinc Pyrithione (ZPT)
No. | Chemical name/INN | CAS number | EC number |
1 | Silicon carbide fibres (with diameter < 3 μm, length > 5 μm and aspect ratio ≥ 3:1) | 409-21-2 308076-74-6 | 206-991-8 |
2 | Tris(2-methoxyethoxy) vinylsilane; 6-(2-methoxyethoxy)- 6-vinyl-2,5,7,10-tetraoxa-6-silaundecane | 1067-53-4 | 213-934-0 |
3 | Dioctyltin dilaurate; [1] stannane, dioctyl-, bis (coco acyloxy) derivs. [2] | 3648-18-8 [1] 91648- 39-4 [2] | 222-883-3 [1] 293-901-5 [2] |
4 | Dibenzo[def,p]chrysene; dibenzo[a,l]pyrene | 191-30-0 | 205-886-4 |
5 | Ipconazole (ISO); (1RS,2SR,5RS;1RS,2SR,5SR)-2-(4-chlorobenzyl)-5-isopropyl-1- (1H-1,2,4-triazol-1-ylmethyl)cyclopentanol | 125225-28-7 115850-69-6 115937-89-8 | - |
6 | Bis(2-(2-methoxyethoxy)ethyl)ether; tetraglyme | 143-24-8 | 205-594-7 |
7 | Paclobutrazol (ISO); (2RS,3RS)-1-(4-chlorophenyl)-4,4-dimethyl- 2-(1H-1,2,4-triazol-1- yl)pentan-3-ol | 76738-62-0 | - |
8 | 2,2-bis(bromomethyl) propane-1,3-diol | 3296-90-0 | 221-967-7 |
9 | 2-(4-tert-butylbenzyl) propionaldehyde | 80-54-6 | 201-289-8 |
10 | Diisooctyl phthalate | 27554-26-3 | 248-523-5 |
11 | 2-methoxyethyl acrylate | 3121-61-7 | 221-499-3 |
12 | Sodium N-(hydroxymethyl)glycinate; [formaldehyde released from sodium N-(hydroxymethyl)glycinate] if the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, in the mixture as placed on the market is ≥ 0,1 % w/w | 70161-44-3 | 274-357-8 |
13 | Pyrithione zinc; (T-4)- bis[1-(hydroxy-.kappa.O)pyridine-2(1H)- thionato-.kappa.S]zinc | 13463-41-7 | 236-671-3 |
14 | Flurochloridone (ISO); 3-chloro-4-(chloromethyl)-1-[3-(trifluoromethyl)phenyl]pyrrolidin-2-one | 61213-25-0 | 262-661-3 |
15 | 3-(difluoromethyl)-1- methyl-N-(3',4',5'-trifluorobiphenyl-2-yl) pyrazole-4-carboxamide; fluxapyroxad | 907204-31-3 | - |
16 | N-(hydroxymethyl)acrylamide; methylolacrylamide; [NMA] | 924-42-5 | 213-103-2 |
17 | 5-fluoro-1,3-dimethyl-N-[2-(4- methylpentan-2-yl) phenyl]-1H-pyrazole- 4-carboxamide; 2'- [(RS)-1,3-dimethylbutyl]-5-fluoro-1,3-dimethylpyrazole-4-carboxanilide; penflufen | 494793-67-8 | - |
18 | Iprovalicarb (ISO); isopropyl [(2S)-3- methyl-1-{[1-(4- methylphenyl)ethyl] amino}-1-oxobutan-2- yl]carbamate | 140923-17-7 | - |
19 | Dichlorodioctylstannane | 3542-36-7 | 222-583-2 |
20 | Mesotrione (ISO); 2-[4-(methylsulfonyl)- 2-nitrobenzoyl]-1,3- cyclohexanedione | 104206-82-8 | - |
21 | Hymexazol (ISO); 3-hydroxy-5-methylisoxazole | 10004-44-1 | 233-000-6 |
22 | Imiprothrin (ISO); reaction mass of: [2,4- dioxo-(2-propyn-1-yl) imidazolidin-3-yl] methyl(1R)-cis-chrysanthemate; [2,4-dioxo-(2-propyn-1-yl) imidazolidin-3-yl] methyl(1R)-trans-chrysanthemate | 72963-72-5 | 428-790-6 |
23 | Bis(α,α-dimethylbenzyl) peroxide | 80-43-3; | 201-279-3’ |
2. Restricted ingredients: one revised and two deleted
Status | Chemical Name/INN | Name of Common Ingredients Glossary | CAS number | EC number | Product type, Body parts | Maximum concentration in ready for use preparation | Other |
Revision | Water-soluble zinc salts with the exception of zinc 4- hydroxy-benzenesulphonate (entry 25) and zinc pyrithione (entry 101 and Annex V entry 8) (Annex II, entry X) | Zinc acetate, zinc chloride, zinc gluconate, zinc glutamate | 1 % (as zinc) | ||||
Deletion | 2-(4-tert-Butylbenzyl)propionaldehyde | Butylphenyl methylpropional | 80-54-6 | 201-289-8 | The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds: — 0.,001 % in leave-on products — 0.,01 % in rinse-off products | ||
Deletion | Pyrithione zinc | Zinc pyrithione | 13463-41-7 | 236-671-3 | Leave-on hair products | 0.1 % | For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product |
3. Permitted preservatives: one deleted and one revised
Status | Chemical Name/INN | Name of Common Ingredients Glossary | CAS number | EC number | Product type, Body parts | Maximum concentration in ready for use preparation | Other |
Deletion | Pyrithione zinc | Zinc pyrithione | 13463-41-7 | 236-671-3 | 1) Hair products 2) Other products | 1) 1.0% 2) 0.5% | Only in rinse-off products Not to be used in oral products |
Revision | Sodium hydroxymethylamino acetate | Sodium Hydroxymethylglycinate | 70161-44-3 | 274-357-8 | 0.5% | Not to be used if the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, if the mixture as placed on the market is ≥ 0.,1 % w/w’ |
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